Status:
COMPLETED
A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Asthma
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose d...
Eligibility Criteria
Inclusion
- Asthma diagnosis for greater than or equal to (\>/=) 12 months prior to Visit 1
- Bronchodilator response during screening
- Pre-bronchodilator FEV1 of 40 percent (%) - 90% predicted at both Visits 2 and 3
- On high dose ICS therapy for \>/= 6 months prior to Visit 1
- On an eligible second controller medication for 6 months prior to Visit 1
- Uncontrolled asthma as defined by the protocol both during screening and at the time of randomization
- Demonstrated adherence with controller medication during the screening period
Exclusion
- History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
- Maintenance oral corticosteroid therapy within 3 months prior to Visit 1
- Treatment with systemic (oral, intravenous \[IV\], or intramuscular \[IM\]) corticosteroids within 4 weeks prior to Visit 1 or during the screening period
- Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study
- Infection that meets the following criteria: Any infection requiring hospital admission or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; any active infection that required treatment with oral antibiotics within 2 weeks prior to Visit 1 or during screening; upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
- History of active tuberculosis requiring treatment
- Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- History of cystic fibrosis, bronchiectasis, and/or other clinically significant lung disease other than asthma
- Diagnosis or history of malignancy or current evaluation for potential malignancy
- Current smoker or former smoker with a history of greater than (\>) 10 pack-years
- History of alcohol or drug abuse
- Past and/or current use of any anti- interleukin (IL) -13 or anti-IL-4/IL-13 therapy, including lebrikizumab
- Use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5 drug half-lives (whichever is longer) prior to Visit 1
- Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening
- History of bronchial thermoplasty
Key Trial Info
Start Date :
August 31 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2016
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT01875003
Start Date
August 31 2013
End Date
December 28 2016
Last Update
May 16 2017
Active Locations (165)
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1
Allergy Associates of Tucson
Tucson, Arizona, United States, 85716
2
Kaiser Permanente Los Angeles
Los Angeles, California, United States, 90027
3
Southern California Research Center
Mission Viejo, California, United States, 92691
4
Allergy & Asthma Consultants
Redwood City, California, United States, 94063